Director, Quality Inspection Management
Listed on 2026-09-14
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Quality Assurance - QA/QC
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Healthcare
Data Scientist
Role:
Lead inspection management and regulatory compliance for Celldex as it transitions to a commercial-stage biotech, ensuring readiness for FDA, EMA, MHRA, Health Canada inspections, partner audits, and launch activities.
Responsibilities:Responsibilities: develop and sustain inspection readiness programs across Quality, Manufacturing, Supply Chain, Regulatory, Clinical, and Commercial functions; oversee inspection responses and CAPA follow-ups; establish metrics for performance tracking; collaborate with CDMOs to prepare for inspections and address 'Hot Topics.'
Qualifications:Qualifications:
Bachelor's in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related; 10+ years in GMP Quality Assurance, Regulatory Inspection Management, or related fields within biotech/pharma; proven experience leading FDA and international inspections; experience with biologics, monoclonal antibodies, sterile products, or advanced therapeutics; familiarity with clinical and commercial stages, supply networks, and post-approval operations.
High Value: biologics, monoclonal antibodies, sterile products; biologics development; GMP compliance; global regulatory inspections; clinical to commercial transition.
Work Setup:Work Setup:
Not specified; focus on cross-functional and global coordination.
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